Viewray, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0676-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Product Classification:

Class II

Date Initiated: March 3, 2019

Date Posted: December 18, 2019

Recall Number: Z-0676-2020

Event ID: 84303

Reason for Recall:

Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

Status: Terminated

Product Quantity: 24 Systems

Code Information:

Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999

Distribution Pattern:

US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

Voluntary or Mandated:

Voluntary: Firm initiated